Improving cognitive function in breast cancer survivors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to evaluate the feasibility and preliminary effects of metacognitive strategy training (MCST) on improving cognition, activity performance, and quality of life in breast cancer survivors experiencing cancer-related cognitive impairment (CRCI). The study will compare the effects of the Cognitive Orientation to daily Occupational Performance (CO-OP) approach against an inactive control group. Participants will be taught general cognitive strategies that can be applied to various tasks, addressing deficits in executive functioning, memory, and processing speed. The study also seeks to explore the neurophysiological changes associated with the intervention.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* self-reported CRCI (Global Rating of Cognition dysfunction as "Moderately" "Strongly "or "Extremely" AND a Cognitive Failures Questionnaire1 (CFQ) score \>30)
* completed treatment for active cancer diagnosis (invasive ductal or lobular BrCA Stages I, II, or III) at least 6 months but not greater than 3 years prior to participation
* able to read, write, and speak English fluently
* able to provide valid informed consent
* have a life expectancy of greater than 6 months at time of enrollment
* on stable doses (i.e., no changes in past 90 days) of medications that are known to impact cognitive function (i.e., anti-depressants)

Exclusion Criteria:

* prior cancer diagnoses of other sites with evidence of active disease within the past year
* active diagnoses of any acute or chronic brain-related neurological conditions that can alter normal brain anatomy or function (e.g., Parkinson's disease, dementia, cerebral infarcts) dementia symptoms as indicated by a score of \<23 on the Montreal Cognitive Assessment (MoCA)
* severe depressive symptoms (Personal Health Questionnaire-9 (PHQ-9) score of ≥21)
* history of severe traumatic brain injury, prolonged loss of consciousness (e.g., coma)
* conditions contraindicated for MRI (e.g., electrical implants, pumps, claustrophobia)
* blue-yellow colorblindness
* pregnancy

The screening methods identified in parentheses next to appropriate inclusion/exclusion criteria will be used to verify appropriate selection of study participants.

Where it's running

• University of Missouri
  Columbia, Missouri, United States Recruiting

Study contacts

• Principal investigator: Anna E Boone, PhD, OTR/L — University of Missouri Occupational Therapy
• Study coordinator: Anna E. Boone, PhD, OTR/L
• Email: booneae@umsystem.edu
• Phone: 5738827023

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.